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NCT ID: NCT03013504 Completed - Clinical trials for HER2 Positive Breast Cancer

A Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of HD201 to Herceptin® in HER2+ Early Breast Cancer Patients

TROIKA
Start date: February 19, 2018
Phase: Phase 3
Study type: Interventional

In the TROIKA study, the proposed biosimilar HD201 will be compared to its reference product Herceptin®. The aim of the study is to demonstrate equivalence of HD201 and Herceptin® in terms of efficacy, safety and pharmacokinetics.

NCT ID: NCT03006068 Active, not recruiting - Clinical trials for Ulcerative Colitis (UC)

A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)

U-ACHIEVE
Start date: January 31, 2017
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had loss of response during the maintenance period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy 3.

NCT ID: NCT03004924 Completed - Clinical trials for Bacterial Conjunctivitis

Treatment of Bacterial Conjunctivitis With SHP640 Compared to PVP-Iodine and Placebo

Start date: March 29, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with bacterial conjunctivitis.

NCT ID: NCT03003520 Completed - Clinical trials for Lymphoma, Large B-Cell, Diffuse

A Study of Durvalumab in Combination With R-CHOP or Lenalidomide Plus R-CHOP in Previously Untreated High-Risk Diffuse Large B-Cell Lymphoma

Start date: February 28, 2017
Phase: Phase 2
Study type: Interventional

This Phase 2, two-arm, open-label study is designed to evaluate the safety, clinical activity, and predictive biomarkers of durvalumab in combination with R-CHOP or R2-CHOP, followed by durvalumab consolidation therapy in previously untreated subjects with high-risk diffuse large B-cell lymphoma (DLBCL). Induction treatment with R-CHOP (± lenalidomide) will last for a total of up to 6 to 8 treatment cycles (21 day cycles), and the total time on study treatment, including durvalumab consolidation, will last up to 12 months. On 05-Sep-2017, the US FDA has issued a Partial Clinical Hold on this study resulting in the discontinuation of enrollment into Arm B (Durvalumab + Lenalidomide + R-CHOP). After the US FDA Partial Clinical Hold, new eligible participants have been enrolled in Arm A (Durvalumab + R-CHOP).

NCT ID: NCT02998541 Terminated - Clinical trials for Adenoviral Conjunctivitis

Treatment of Adenoviral Conjunctivitis With SHP640 Compared to Povidone-iodine (PVP-I) and Placebo

Start date: March 27, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if an investigational treatment is effective compared with placebo and PVP-Iodine in the treatment of adults and children with adenoviral conjunctivitis.

NCT ID: NCT02993406 Completed - Clinical trials for Cardiovascular Diseases

Evaluation of Major Cardiovascular Events in Participants With, or at High Risk for, Cardiovascular Disease Who Are Statin Intolerant Treated With Bempedoic Acid (ETC-1002) or Placebo

CLEAR Outcomes
Start date: December 22, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if treatment with bempedoic acid (ETC-1002) versus placebo decreases the risk of cardiovascular events in participants who have or are at high risk for cardiovascular disease and are statin intolerant.

NCT ID: NCT02989194 Completed - Influenza Clinical Trials

Study of an Investigational Monoclonal Antibody, VIS410, in Subjects With Uncomplicated Influenza A

Start date: January 6, 2017
Phase: Phase 2
Study type: Interventional

This is a Phase 2a randomized, double-blind, placebo-controlled study designed to assess the safety and tolerability of an investigational monoclonal antibody, VIS410, in subjects with uncomplicated influenza.

NCT ID: NCT02979431 Completed - Clinical trials for Respiratory Syncytial Virus Lower Respiratory Tract Infection

Dose Ranging Study of ALX-0171 in Infants Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection

Respire
Start date: January 11, 2017
Phase: Phase 2
Study type: Interventional

The primary objective is to evaluate the anti-viral effect and safety of different doses of inhaled ALX-0171 in subjects hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection (RSV LRTI). The secondary objective is to evaluate the clinical activity, pharmacokinetic (PK) properties, pharmacodynamic (PD) effect and immunogenicity of different doses of inhaled ALX-0171.

NCT ID: NCT02964949 Completed - Atrial Fibrillation Clinical Trials

Comparison of Two Doses of Edoxaban Using Different Tests (Assays) and Clinical Outcomes

Start date: January 24, 2017
Phase: N/A
Study type: Interventional

Atrial fibrillation is when the heart's two upper chambers (called atria) beat chaotically and irregularly, out of coordination with the two lower chambers (called ventricles) of the heart. This can lead to blood clots forming in the heart chamber. Patients with atrial fibrillation will be treated with either 60 mg or 75 mg of edoxaban for up to 12 months, with a 2-4 week follow-up, after which their participation is complete. Blood samples will be collected before the first dose of study drug (Day 0), and on Days 30, 90 and 360 (at pre dose, 1-2 hours post dose and 4-8 hours post-dose).

NCT ID: NCT02957682 Completed - Clinical trials for Hypercholesterolemia

Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo

Start date: November 2, 2016
Phase: Phase 4
Study type: Interventional

The main purpose of this study is to evaluate the effect on mental state (known as "neurocognitive function") with use of Praluent.